A Phase III Study of Datopotamab Deruxtecan Versus Standard Chemotherapy as Initial Treatment for People with Inoperable or Metastatic Triple-Negative Breast Cancer Who Cannot Have Immunotherapy


Full Title

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast02) (WIRB)


This study is comparing the effectiveness of the drug datopotamab deruxtecan (Dato-DXd) with standard chemotherapy as initial treatment for people with inoperable or metastatic triple-negative breast cancer who cannot receive immunotherapy. Dato-DXd is an “antibody-drug conjugate.” The antibody part, datopotamab, attaches to cells with a protein called TROP2 on their surfaces. When this attachment happens, a chemotherapy-like molecule called deruxtecan (DXd) is released into the cancer cell, damaging or killing it.

Participants in this study will be randomly assigned to receive either Dato-DXd or their doctor’s choice of standard chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin, and/or eribulin). The treatments are given intravenously (by vein), except for capecitabine, which is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic triple-negative breast cancer and not be able to receive immunotherapy.
  • The serious side effects of prior treatments must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information about this study and to ask about eligibility, please contact the office of Dr. Tiffany A. Traina at 646-888-4558.




Phase III (phase 3)




ClinicalTrials.gov ID